Specific implementation methods of medical equipment unique coding are issued

On the afternoon of July 3, the State Administration of Pharmaceutical Supervision issued a notice that the pilot work of the unique identification system for medical devices should be arranged.

In order to implement the "Opinions on Deepening the Reform of Examination and Approval System and Encouraging the Innovation of Medical Devices" of the Central Office of the Communist Party of China and the General Office of the State Council and the "Key Tasks for Deep " The State Drug Administration, in conjunction with the State Health Commission, has carried out pilot work on the unique identification system for medical devices. The following plans are now formulated.

(1) Establish the framework of the unique identification system for medical devices. To realize the functions of creating, endowing, uploading, downloading and sharing the unique identification of medical devices, to form the unique identification database of pilot varieties of medical devices, and to establish a unique identification data platform.

(2) Pilot application of unique identification in the production, operation, circulation and use of medical devices, and the formation of demonstration application standards and norms. 

(3) Explore the application of unique identification in adverse event reporting, product recall and traceability of medical devices.

(4) Explore the application of the unique identification of medical devices in the fields of health and medical insurance, and realize the data sharing of information platforms such as registration, approval, clinical application and medical insurance settlement.

Pilot scope and variety announcement

(1) Participating units. The State Drug Administration, the State Health and Health Commission, some provincial drug supervision and administration departments, provincial health and health administration departments, selected registrants of medical devices at home and abroad, business enterprises, circulation enterprises, users, associations of societies and coder agencies, etc.

(2) Pilot varieties. With heart, brain implants, prosthesis and other high-risk implant (introduction) medical devices as the key varieties, while covering different types of typical products.

All parties have requirements for

(1) medical device registrant. According to the rules and standards of the unique identification system, the unique identification is created and given to its products, the upload of the unique identification database data is completed, the unique identification information is provided to downstream enterprises or users, and the application mode of the unique identification in product traceability is explored, and the corresponding operational specifications are formed.

(2) Managing circulation enterprises. Form a unique identification workflow in medical device operation and circulation business, verify multi-code parallel operation, develop a unique identification database data and business system docking operation process, explore collaborative mechanism with medical device registrants, users, regulatory authorities.

(3) User Unit. Doing a good job of docking the unique identification with the medical business system, exploring the connection between the unique identification and the medical device management, clinical application and other systems.

(4) Coding mechanism. To formulate standards and guidelines for the establishment of unique labels for this institution, to guide the registrants of medical devices to carry out the work of creating and assigning unique labels, to verify that the establishment standards of unique labels for this institution conform to the relevant standards formulated by the State Drug Administration, to ensure the uniqueness of unique labels, and to verify the unique labels formulated in accordance with its standards. Recognize the readability in circulation, use and other links.

(5) Industry Association. Organize relevant enterprises to actively participate in the pilot work of unique identification of medical devices, collect and summarize feedback from pilot enterprises regularly, and put forward suggestions for improvement.

(6) The relevant units of the National Health Commission. To organize and study the requirement of the construction of the unique identification system in health management, put forward the requirement of data sharing, organize some users to carry out the pilot application of the unique identification system, and further standardize the clinical application management of medical devices.

(7) Provincial Health Management Department. In conjunction with the provincial drug supervision and administration departments, the user units in their respective administrative regions will participate in the pilot project of the unique identification, explore the application mode and method of the unique identification in daily health management, and form the experience that can be popularized.

(8) Relevant units of the State Drug Administration. Responsible for overall promoting the pilot work, conducting pilot training, verifying the overall functions of the unique identification system rules, standards and database platform for medical devices, trying to apply the unique identification in adverse event reports, product recalls and other regulatory work, and promoting the convergence and application of the unique identification in the fields of medicine, medical treatment and medical insurance.

Pilot schedule

(1) In July 2019, pilot varieties and participating units were determined. Establish a collaborative working group of the pilot departments of the Unique Identification System to issue the pilot work programme. Organize pilot training and start pilot work. The pilot units formulate implementation plans, refine tasks and measures, and clarify acceptance indicators.

(2) From August to November 2019, the organization established and endowed the unique identification of medical devices.

(3) From December 2019 to February 2020, organize and verify the unique identification data of medical devices.